Patient reference tool

ABSTRACT

A patient reference device is provided for use during a medical procedure. The patient reference device includes a housing having a back side and a front side, at least three tracking markers attached to the front side of the housing, the housing extending around the at least three tracking markers and beyond a horizontal plane defined by tops of the at least three tracking markers, the housing terminating at a substantially continuous edge, and a sterile cover attached to the substantially continuous edge of the housing for covering the housing and the tracking markers.

TECHNICAL FIELD

The present disclosure is generally related to image guided medical procedures, and more specifically to a patient reference tool.

BACKGROUND

The present disclosure is generally related to image guided medical procedures using a surgical instrument, such as a fibre optic scope, an optical coherence tomography (OCT) probe, a micro ultrasound transducer, an electronic sensor or stimulator, or an access port based surgery.

In the example of a port-based surgery, a surgeon or robotic surgical system may perform a surgical procedure involving tumor resection in which the residual tumor remaining after is minimized, while also minimizing the trauma to the intact white and grey matter of the brain. In such procedures, trauma may occur, for example, due to contact with the access port, stress to the brain matter, unintentional impact with surgical devices, and/or accidental resection of healthy tissue. A key to minimizing trauma is ensuring that the spatial reference of the patient as understood by the surgical system is as accurate as possible.

FIG. 1 illustrates the insertion of an access port into a human brain, for providing access to internal brain tissue during a medical procedure. In FIG. 1, access port 12 is inserted into a human brain 10, providing access to internal brain tissue. Access port 12 may include such instruments as catheters, surgical probes, or cylindrical ports such as the NICO Brain Path. Surgical tools and instruments may then be inserted within the lumen of the access port in order to perform surgical, diagnostic or therapeutic procedures, such as resecting tumors as necessary. The present disclosure applies equally well to catheters, DBS needles, a biopsy procedure, and also to biopsies and/or catheters in other medical procedures performed on other parts of the body.

In the example of a port-based surgery, a straight or linear access port 12 is typically guided down a sulci path of the brain. Surgical instruments would then be inserted down the access port 12.

Optical tracking systems, used in the medical procedure, track the position of a part of the instrument that is within line-of-site of the optical tracking camera. These optical tracking systems also require a reference to the patient to know where the instrument is relative to the target (e.g., a tumour) of the medical procedure.

Conventional systems have shortcomings with respect to establishing the reference to the patient because conventional systems create problems with either sterility or accuracy. Therefore, there is a need for an improved patient reference tool.

SUMMARY

One aspect of the present disclosure provides a patient reference device for use during a medical procedure. The patient reference device comprises a housing having a back side and a front side, at least three tracking markers attached to the front side of the housing, the housing extending around the at least three tracking markers and beyond a horizontal plane defined by tops of the at least three tracking markers, the housing terminating at a substantially continuous edge, and a sterile cover attached to the substantially continuous edge of the housing for covering the housing and the tracking markers.

Another aspect of the present disclosure provides a medical navigation system comprising a patient reference device for use during a medical procedure, a sensor attached to the patient reference device, and a controller at least electrically coupled to the sensor. The sensor provides a signal to the controller indicating movement of the patient reference device. The patient reference device has a housing having a back side and a front side, at least three tracking markers attached to the front side of the housing, the housing extending around the at least three tracking markers and beyond a horizontal plane defined by tops of the at least three tracking markers, the housing terminating at a substantially continuous edge.

Another aspect of the present disclosure provides a patient reference device for use during a medical procedure. The patient reference device comprises a housing having a back side and a front side, at least one tracking marker attached to the front side of the housing, the housing extending around the at least one tracking marker and beyond a top of the at least one tracking marker, the housing terminating at a substantially continuous edge, and a sterile cover attached to the substantially continuous edge of the housing for covering the housing and the tracking marker.

Another aspect of the present disclosure provides a kit comprising parts that can be assembled to form the patient reference device. The kit may include instructions for assembling the parts.

A further understanding of the functional and advantageous aspects of the disclosure can be realized by reference to the following detailed description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will now be described, by way of example only, with reference to the drawings, in which:

FIG. 1 illustrates the insertion of an access port into a human brain, for providing access to internal brain tissue during a medical procedure;

FIG. 2 shows an exemplary navigation system to support minimally invasive access port-based surgery;

FIG. 3 is a block diagram illustrating a control and processing system that may be used in the navigation system shown in FIG. 2;

FIG. 4A is a flow chart illustrating a method involved in a surgical procedure using the navigation system of FIG. 2;

FIG. 4B is a flow chart illustrating a method of registering a patient for a surgical procedure as outlined in FIG. 4A;

FIG. 5 is a perspective drawing illustrating an exemplary arm for holding a patient reference device;

FIG. 6A is a perspective drawing illustrating an exemplary patient reference device with cover detached;

FIG. 6B is a perspective drawing illustrating an exemplary patient reference device with cover attached;

FIG. 7 is a front view of the exemplary patient reference device shown in FIG. 6B;

FIG. 8 is a side view of the exemplary patient reference device shown in FIG. 6B;

FIG. 9A is a perspective drawing illustrating an environmental context of the exemplary patient reference device shown in FIG. 6;

FIG. 9B is a perspective drawing showing the exemplary patient reference device shown in FIG. 6 installed;

FIG. 9C is a perspective drawing showing the exemplary patient reference device shown in FIG. 6 installed;

FIG. 9D is a perspective drawing showing the exemplary patient reference device shown in FIG. 6 installed with sterile draping in place; and

FIG. 9E is a perspective drawing showing the exemplary patient reference device shown in FIG. 6 installed with sterile draping in place.

DETAILED DESCRIPTION

Various embodiments and aspects of the disclosure will be described with reference to details discussed below. The following description and drawings are illustrative of the disclosure and are not to be construed as limiting the disclosure. Numerous specific details are described to provide a thorough understanding of various embodiments of the present disclosure. However, in certain instances, well-known or conventional details are not described in order to provide a concise discussion of embodiments of the present disclosure.

As used herein, the terms, “comprises” and “comprising” are to be construed as being inclusive and open ended, and not exclusive. Specifically, when used in the specification and claims, the terms, “comprises” and “comprising” and variations thereof mean the specified features, steps or components are included. These terms are not to be interpreted to exclude the presence of other features, steps or components.

As used herein, the term “exemplary” means “serving as an example, instance, or illustration,” and should not be construed as preferred or advantageous over other configurations disclosed herein.

As used herein, the terms “about” and “approximately” are meant to cover variations that may exist in the upper and lower limits of the ranges of values, such as variations in properties, parameters, and dimensions. In one non-limiting example, the terms “about” and “approximately” mean plus or minus 10 percent or less.

Unless defined otherwise, all technical and scientific terms used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art. Unless otherwise indicated, such as through context, as used herein, the following terms are intended to have the following meanings:

As used herein, the phrase “access port” refers to a cannula, conduit, sheath, port, tube, or other structure that is insertable into a subject, in order to provide access to internal tissue, organs, or other biological substances. In some embodiments, an access port may directly expose internal tissue, for example, via an opening or aperture at a distal end thereof, and/or via an opening or aperture at an intermediate location along a length thereof. In other embodiments, an access port may provide indirect access, via one or more surfaces that are transparent, or partially transparent, to one or more forms of energy or radiation, such as, but not limited to, electromagnetic waves and acoustic waves.

As used herein the phrase “intraoperative” refers to an action, process, method, event or step that occurs or is carried out during at least a portion of a medical procedure. Intraoperative, as defined herein, is not limited to surgical procedures, and may refer to other types of medical procedures, such as diagnostic and therapeutic procedures.

Embodiments of the present disclosure provide imaging devices that are insertable into a subject or patient for imaging internal tissues, and methods of use thereof. Some embodiments of the present disclosure relate to minimally invasive medical procedures that are performed via an access port, whereby surgery, diagnostic imaging, therapy, or other medical procedures (e.g. minimally invasive medical procedures) are performed based on access to internal tissue through the access port.

Referring to FIG. 2, an exemplary navigation system environment 200 is shown, which may be used to support navigated image-guided surgery. As shown in FIG. 2, surgeon 201 conducts a surgery on a patient 202 in an operating room (OR) environment. A medical navigation system 205 comprising an equipment tower, tracking system, displays and tracked instruments assist the surgeon 201 during his procedure. An operator 203 is also present to operate, control and provide assistance for the medical navigation system 205.

Referring to FIG. 3, a block diagram is shown illustrating a control and processing system 300 that may be used in the medical navigation system 200 shown in FIG. 3 (e.g., as part of the equipment tower). As shown in FIG. 3, in one example, control and processing system 300 may include one or more processors 302, a memory 304, a system bus 306, one or more input/output interfaces 308, a communications interface 310, and storage device 312. Control and processing system 300 may be interfaced with other external devices, such as tracking system 321, data storage 342, and external user input and output devices 344, which may include, for example, one or more of a display, keyboard, mouse, sensors attached to medical equipment, foot pedal, and microphone and speaker. Data storage 342 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon. In the example shown in FIG. 3, data storage device 342 includes identification data 350 for identifying one or more medical instruments 360 and configuration data 352 that associates customized configuration parameters with one or more medical instruments 360. Data storage device 342 may also include preoperative image data 354 and/or medical procedure planning data 356. Although data storage device 342 is shown as a single device in FIG. 3, it will be understood that in other embodiments, data storage device 342 may be provided as multiple storage devices.

Medical instruments 360 are identifiable by control and processing unit 300. Medical instruments 360 may be connected to and controlled by control and processing unit 300, or medical instruments 360 may be operated or otherwise employed independent of control and processing unit 300. Tracking system 321 may be employed to track one or more of medical instruments 360 and spatially register the one or more tracked medical instruments to an intraoperative reference frame. For example, medical instruments 360 may include tracking spheres that may be recognizable by a tracking camera 307. In one example, the tracking camera 307 may be an infrared (IR) tracking camera. In another example, as sheath placed over a medical instrument 360 may be connected to and controlled by control and processing unit 300.

Control and processing unit 300 may also interface with a number of configurable devices, and may intraoperatively reconfigure one or more of such devices based on configuration parameters obtained from configuration data 352. Examples of devices 320, as shown in FIG. 3, include one or more external imaging devices 322, one or more illumination devices 324, a robotic arm, one or more projection devices 328, and one or more displays 205, 211.

Exemplary aspects of the disclosure can be implemented via processor(s) 302 and/or memory 304. For example, the functionalities described herein can be partially implemented via hardware logic in processor 302 and partially using the instructions stored in memory 304, as one or more processing modules or engines 370. Example processing modules include, but are not limited to, user interface engine 372, tracking module 374, motor controller 376, image processing engine 378, image registration engine 380, procedure planning engine 382, navigation engine 384, and context analysis module 386. While the example processing modules are shown separately in FIG. 3, in one example the processing modules 370 may be stored in the memory 304 and the processing modules may be collectively referred to as processing modules 370.

It is to be understood that the system is not intended to be limited to the components shown in FIG. 3. One or more components of the control and processing system 300 may be provided as an external component or device. In one example, navigation module 384 may be provided as an external navigation system that is integrated with control and processing system 300.

Some embodiments may be implemented using processor 302 without additional instructions stored in memory 304. Some embodiments may be implemented using the instructions stored in memory 304 for execution by one or more general purpose microprocessors. Thus, the disclosure is not limited to a specific configuration of hardware and/or software.

While some embodiments can be implemented in fully functioning computers and computer systems, various embodiments are capable of being distributed as a computing product in a variety of forms and are capable of being applied regardless of the particular type of machine or computer readable media used to actually effect the distribution.

At least some aspects disclosed can be embodied, at least in part, in software. That is, the techniques may be carried out in a computer system or other data processing system in response to its processor, such as a microprocessor, executing sequences of instructions contained in a memory, such as ROM, volatile RAM, non-volatile memory, cache or a remote storage device.

A computer readable storage medium can be used to store software and data which, when executed by a data processing system, causes the system to perform various methods. The executable software and data may be stored in various places including for example ROM, volatile RAM, nonvolatile memory and/or cache. Portions of this software and/or data may be stored in any one of these storage devices.

Examples of computer-readable storage media include, but are not limited to, recordable and non-recordable type media such as volatile and non-volatile memory devices, read only memory (ROM), random access memory (RAM), flash memory devices, floppy and other removable disks, magnetic disk storage media, optical storage media (e.g., compact discs (CDs), digital versatile disks (DVDs), etc.), among others. The instructions may be embodied in digital and analog communication links for electrical, optical, acoustical or other forms of propagated signals, such as carrier waves, infrared signals, digital signals, and the like. The storage medium may be the internet cloud, or a computer readable storage medium such as a disc.

At least some of the methods described herein are capable of being distributed in a computer program product comprising a computer readable medium that bears computer usable instructions for execution by one or more processors, to perform aspects of the methods described. The medium may be provided in various forms such as, but not limited to, one or more diskettes, compact disks, tapes, chips, USB keys, external hard drives, wire-line transmissions, satellite transmissions, internet transmissions or downloads, magnetic and electronic storage media, digital and analog signals, and the like. The computer useable instructions may also be in various forms, including compiled and non-compiled code.

According to one aspect of the present application, one purpose of the navigation system 205, which may include control and processing unit 300, is to provide tools to the neurosurgeon that will lead to the most informed, least damaging neurosurgical operations. In addition to removal of brain tumours and intracranial hemorrhages (ICH), the navigation system 205 can also be applied to a brain biopsy, a functional/deep-brain stimulation, a catheter/shunt placement procedure, open craniotomies, endonasal/skull-based/ENT, spine procedures, and other parts of the body such as breast biopsies, liver biopsies, etc. While several examples have been provided, aspects of the present disclosure may be applied to any suitable medical procedure.

Referring to FIG. 4A, a flow chart is shown illustrating a method 400 of performing a port-based surgical procedure using a navigation system, such as the medical navigation system 200 described in relation to FIG. 2. At a first block 402, the port-based surgical plan is imported. A detailed description of the process to create and select a surgical plan is outlined in the international publication WO/2014/139024 “PLANNING, NAVIGATION AND SIMULATION SYSTEMS AND METHODS FOR MINIMALLY INVASIVE THERAPY”, which claims priority to U.S. Provisional Patent Application Ser. Nos. 61/800,155 and 61/924,993, which are both hereby incorporated by reference in their entirety.

Once the plan has been imported into the navigation system at the block 402, the patient is affixed into position using a body holding mechanism. The head position is also confirmed with the patient plan in the navigation system (block 404), which in one example may be implemented by the computer or controller forming part of the equipment tower 201.

Next, registration of the patient is initiated (block 406). The phrase “registration” or “image registration” refers to the process of transforming different sets of data into one coordinate system. Data may includes multiple photographs, data from different sensors, times, depths, or viewpoints. The process of “registration” is used in the present application for medical imaging in which images from different imaging modalities are co-registered. Registration is used in order to be able to compare or integrate the data obtained from these different modalities.

Those skilled in the relevant arts will appreciate that there are numerous registration techniques available and one or more of the techniques may be applied to the present example. Non-limiting examples include intensity-based methods that compare intensity patterns in images via correlation metrics, while feature-based methods find correspondence between image features such as points, lines, and contours. Image registration methods may also be classified according to the transformation models they use to relate the target image space to the reference image space. Another classification can be made between single-modality and multi-modality methods. Single-modality methods typically register images in the same modality acquired by the same scanner or sensor type, for example, a series of magnetic resonance (MR) images may be co-registered, while multi-modality registration methods are used to register images acquired by different scanner or sensor types, for example in magnetic resonance imaging (MRI) and positron emission tomography (PET). In the present disclosure, multi-modality registration methods may be used in medical imaging of the head and/or brain as images of a subject are frequently obtained from different scanners. Examples include registration of brain computerized tomography (CT)/MRI images or PET/CT images for tumor localization, registration of contrast-enhanced CT images against non-contrast-enhanced CT images, and registration of ultrasound and CT.

Referring now to FIG. 4B, a flow chart is shown illustrating a method involved in registration block 406 as outlined in FIG. 4A, in greater detail. If the use of fiducial touch points (440) is contemplated, the method involves first identifying fiducials on images (block 442), then touching the touch points with a tracked instrument (block 444). Next, the navigation system computes the registration to reference markers (block 446).

Alternately, registration can also be completed by conducting a surface scan procedure (block 450). The block 450 is presented to show an alternative approach, but may not typically be used when using a fiducial pointer. First, the face is scanned using a 3D scanner (block 452). Next, the face surface is extracted from MR/CT data (block 454). Finally, surfaces are matched to determine registration data points (block 456).

Upon completion of either the fiducial touch points (440) or surface scan (450) procedures, the data extracted is computed and used to confirm registration at block 408, shown in FIG. 4A.

Referring back to FIG. 4A, once registration is confirmed (block 408), the patient is draped (block 410). Typically, draping involves covering the patient and surrounding areas with a sterile barrier to create and maintain a sterile field during the surgical procedure. The purpose of draping is to eliminate the passage of microorganisms (e.g., bacteria) between non-sterile and sterile areas. At this point, conventional Navigation systems require that the non-sterile patient reference is replaced with a sterile patient reference of identical geometry location and orientation. Numerous mechanical methods may be used to minimize the displacement of the new sterile patient reference relative to the non-sterile one that was used for registration but it is inevitable that some error will exist. This error directly translates into registration error between the surgical field and pre-surgical images. In fact, the further away points of interest are from the patient reference, the worse the error will be.

Upon completion of draping (block 410), the patient engagement points are confirmed (block 412) and then the craniotomy is prepared and planned (block 414).

Upon completion of the preparation and planning of the craniotomy (block 414), the craniotomy is cut and a bone flap is temporarily removed from the skull to access the brain (block 416). Registration data is updated with the navigation system at this point (block 422).

Next, the engagement within craniotomy and the motion range are confirmed (block 418). Next, the procedure advances to cutting the dura at the engagement points and identifying the sulcus (block 420).

Thereafter, the cannulation process is initiated (block 424). Cannulation involves inserting a port into the brain, typically along a sulci path as identified at 420, along a trajectory plan. Cannulation is typically an iterative process that involves repeating the steps of aligning the port on engagement and setting the planned trajectory (block 432) and then cannulating to the target depth (block 434) until the complete trajectory plan is executed (block 424).

Once cannulation is complete, the surgeon then performs resection (block 426) to remove part of the brain and/or tumor of interest. The surgeon then decannulates (block 428) by removing the port and any tracking instruments from the brain. Finally, the surgeon closes the dura and completes the craniotomy (block 430). Some aspects of FIG. 4A are specific to port-based surgery, such portions of blocks 428, 420, and 434, but the appropriate portions of these blocks may be skipped or suitably modified when performing non-port based surgery.

When performing a surgical procedure using a medical navigation system 200, as outlined in connection with FIGS. 4A and 4B, the medical navigation system 200 must acquire and maintain a reference of the location of the tools in use as well as the patient in three dimensional (3D) space. In other words, during a navigated neurosurgery, there needs to be a tracked reference frame that is fixed relative to the patient's skull. During the registration phase of a navigated neurosurgery (e.g., the step 406 shown in FIGS. 4A and 4B), a transformation is calculated that maps the frame of reference of preoperative MRI or CT imagery to the physical space of the surgery, specifically the patient's head. This may be accomplished by the navigation system 200 tracking locations of fiducial markers fixed to the patient's head, relative to the static patient reference frame. The patient reference frame is typically rigidly attached to the head fixation device, such as a Mayfield clamp. Registration is typically performed before the sterile field has been established (e.g., the step 410 shown in FIG. 4A).

Most conventional navigation systems require the patient reference be exchanged during the draping phase (e.g., step 410) and the original patient reference frame used for registration is replaced with a sterile patient reference frame. This exchange can cause a loss of accuracy.

Other conventional systems may require the non-sterile reference frame to be draped with a sterile, transparent plastic surgical drape. Where tracking spheres are used in conjunction with an infrared (IR) tracking camera, visibility through this drape can cause optical distortion of the measured reference position and can cause loss of accuracy. This process is also operator and set-up dependent, being affected by how the sterile drape is positioned and how tightly it is formed around the reference frame.

Also, throughout a navigated surgery, the patient reference frame is sometimes bumped by the surgeon or others involved into the procedure. A bump that is strong enough could cause a shift in the frame's location and therefore create a misregistration.

In order to address the shortcomings of conventional systems outlined above, according to one aspect of the present description, a patient reference design is provided that incorporates a removable sterile cover. According to another aspect of the present description, a sensor may be attached to or embedded in the patient reference frame to provide the medical navigation system 200 with information that can be used to determine when the patient reference frame is bumped with enough force that the frame's location may have to be re-registered.

The sterile drape may include a plastic lens that is placed over the patient reference face containing the tracking markers. In one example, the sterile cover maybe a substantially rigid lens. In one example, the markers could be active IR markers or passive reflective spheres. The sterile cover may not cause significant distortion like a standard drape would. The sterile cover may have a transparent plastic sock that extends downward from the cover to cover the rest of the patient reference and patient reference mounting arm and extension. The patient reference may be designed to permit +/−45 degree line-of-sight between the tracking camera 307 (e.g., a Northern Digital Polaris Spectra) and the patient reference.

Force Sensors and/or accelerometers may be connected to the medical navigation system 200, either wired or wirelessly, and the medical navigation system 200 may display a warning and/or force re-registration if too great of a force and/or acceleration is imparted on the patient reference.

Referring to FIG. 5, an exemplary arm 500 is shown for holding a patient reference device. Arm 500 may also be referred to a patient reference arm 500. Patient reference arm 500 may include a tightening screw 502 for securing the patient reference arm 500 once patient reference arm 500 has been suitably adjusted. Patient reference arm 500 may attach to a Mayfield head holder or other suitable head holding device using mounting bolt 504. In another example, patient reference arm 500 may attach directly to a patient bed so long as the spatial relationship between the receiving device for mounting bolt 504 and the patient's head is static and known by medical navigation system 200. The mounting bolt 504 may secure the patient reference arm 500 to a Mayfield clamp. Once the tightening screw 502 is tightened the arm 500 may not pivot; the user may clock the arm 500 to his desired position using the starbust connection. Once the screw 502 is tightened, a rigid connection between the Mayfield clamp and the arm 500 is provided. While one example of an arm 500 for connecting a patient reference device with a head holding device has been shown, any suitable arm or connecting mechanism may be used according to the design criteria of a particular application.

Referring to FIGS. 6A and 6B, an exemplary patient reference device 600 is shown according to one aspect of the present application. FIG. 6a shows a perspective drawing illustrating the patient reference device 600 with a cover detached. FIG. 6b shows a perspective drawing of the patient reference device 600 with the cover attached. FIG. 7 shows a front view of the patient reference device with the drape attached. FIG. 8 shows a side view of the patient reference device 600 with the drape attached. FIGS. 6-8 are now discussed concurrently.

The patient reference device 600 may be used during a medical procedure. The patient reference device 600 includes a housing 602 having a back side 604 and a front side 606. In one example, at least three tracking markers 608 are attached to the front side 606 of the housing 602. In another example, four or more tracking makers 608 may be used. The tracking markers 608 each have a top 614, generally on the opposite side from where the tracking markers 608 attach to the housing 602. While an example of either three or four tracking markers 608 is provided, any number of tracking markers 608 may be used to meet the design criteria of a particular application. In one example, only one or two tracking markers may be used. In one example, the tracking markers 608 may be passive reflective tracking spheres or active infrared (IR) markers that may be visible to a tracking camera, such as the tracking camera 307 of the medical navigation system 200. In another example, the tracking markers 608 may be active light emitting diodes (LEDs) or a graphical pattern printed on a three dimensional (3D) structure used by a vision system such as the tracking camera to acquire 6 degrees of freedom (DOF).

The housing 602 shown in FIG. 6 is generally disc shaped. However, any suitable shaped housing or frame may be used to meet the design criteria of a particular application. In some examples, the housing 602 may be a solid member, either square shaped or disc shaped and the frame may further have superfluous material removed that is not important to the structural integrity of the housing (e.g., the housing may be generally square shaped or disc shaped with holes formed therein In one example, the housing 602 may be constructed of a metal such as machined aluminum, blasted with aluminum oxide (e.g., 180 grit), and then hard anodized. Both the blasting and anodization processes may result in a matte finish of the housing 602 that may minimize reflection seen by the tracking camera. Naked metallic surfaces or even plastic sometimes lead to poor accuracy for camera based tracking systems due to the presence of reflection, which can be further magnified with the use of a plastic drape on the patient reference 600. The exemplary blasted and anodized aluminum finish may improve tracking performance of the tracking camera without degrading accuracy. While one example of a suitable finish for the housing 602 is provided, any suitable finish of low reflectivity may be used to meet the design criteria of a particular application. In one example, the housing 602 may be made of any suitable type of plastic or metal.

The housing 602 shown in FIGS. 6-8 extends along the back side 604 of the housing 602. The housing 602 further extends beyond a horizontal plane defined by the tops 614 of the tracking markers 608. The housing terminates at an edge 610. In one example, the edge 610 may be substantially continuous, such as forming a shape such as a circle, a square, an oval, or a rectangle in one plane. A sterile cover 612 may be attached to the substantially continuous edge 610 of the housing 602 for covering the housing 602 and the tracking markers 608. In one example, the housing 602 may be generally domed shaped with a flattened back side and the sterile cover 612 may be round. However, the housing 602 may also be pyramid shaped, cone shaped, dome shaped, dish shaped, or of any other suitable shape to meet the design criteria of a particular application. The shape of the sterile cover 612 is then designed to mate appropriately with the shape of the housing 602.

The housing 602 of the patient reference device 600 may be attachable to a patient reference arm, such as the patient reference arm 500 shown in FIG. 5. The patient reference arm 500 may be attachable by way of the mounting bolt 510 to a Mayfield head holder or any other head securing device, such that the patient reference device 600 is rigidly attached in a static location relative to the head securing device.

In one example, the continuous edge 610 may have a seal located on the continuous edge 610 for forming a seal between the housing 602 and the sterile cover 612. In one example, the seal may be attached to the continuous edge 610 using any suitable adhesive. The sterile cover 612 may further have a sterile drape attached thereto for covering the housing 602 and a patient reference arm 500 attached to and holding the patient reference device 600 in position.

In one example, a lens 616 of the sterile cover 612 may be made of a substantially transparent plastic material that can be easily sterilized and has optical properties that are known and controlled such that infrared light passing through the lens 616 of the sterile cover 612 and reflecting off of the tracking markers 608 and passing back through the lens 616 of sterile cover 612 does so without excessive diffraction such that it becomes problematic for the tracking camera (e.g., the tracking camera 307) that is monitoring the tracking markers 608. In one example, the sterile cover 612 could be made of glass, quartz, or sapphire. In some examples, the lens 616 of the sterile cover 612 may have additional optical properties, such as that of a band pass filter that allows infrared light to pass through but blocks any suitable portion of the frequency spectrum on each side of the IR pass band. In another example, the lens 616 of the sterile cover 612 may have the optical properties of a low pass or a high pass optical filter. Alternatively, the optical properties of the lens 616 of the sterile cover 612 may be optimized for passing visible light or only visible light in the example where a graphical pattern is printed on a structure. While some examples have been given for possible optical filter characteristics, any suitable optical filter may be applied to the lens 616 to meet the design criteria of a particular application.

The patient reference device 600 may further have one or more sensors (not shown) attached thereto for providing a signal to a medical navigation system, such as the medical navigation system 205 shown in FIG. 2, which may include the control and processing unit 300 shown in FIG. 3. In one example, the sensor may include, an accelerometer, a force sensor, a gyroscope, a magnetometer, a strain gauge, or any other suitable sensor. The sensor may be either attached to the exterior of the housing 602 or embedded in or integrated into the housing 602. In one example, the patient reference device 600 may have a triaxial accelerometer attached thereto for sensing acceleration in any of the X, Y, and Z directions and providing the signal generated by the accelerometer to the control and processing unit 300. For example, the accelerometer mounted on the patient reference device 600 may be shown in FIG. 3 as one of the external I/O devices 344. The control and processing unit 300 may be programmed (e.g., one of the processing engines 370) to monitor signals from the accelerometer after the patient reference device 600 has been put into position and registered during the registrations phases 406/408 (FIG. 4A).

When the control and processing system 300 detects an acceleration from the accelerometer that indicates that the patient reference device 600 or the patient reference arm 500 has been jolted, perhaps by one of the medical staff accidentally hitting or kicking the patient reference device 600 or the patient reference arm 500, and when the acceleration indicated by the accelerometer exceeds a threshold such that enough force was generated that could have thrown the patient reference device out of its proper fixed position, the control and processing system 300 may respond accordingly. For example, the control and processing system 300 may display a warning on the display 311 to the operator to check the position of the patient reference device 600. In another example, the control and processing system 300 may simply require the operator of the system to reregister the patient reference device 600 to ensure that the position of the patient reference device 600 relative to the head holding device is properly understood by the medical navigation system 200.

Referring now to FIG. 9A, a perspective drawing is shown illustrating an environmental context of the exemplary patient reference device 600 shown in FIG. 6. In FIG. 9A, the patient reference device 600 is shown attached to an arm that fixes the patient reference device 600 in position at the head end of a medical bed for performing a medical procedure in an operating room type environment, as discussed above. Several aspects of the navigation system 205 discussed in connection with FIG. 2 are shown surrounding the medical bed.

Referring now to FIG. 9B, a perspective drawing is shown illustrating the exemplary patient reference device 600 installed. FIG. 9C is a perspective drawing showing the exemplary patient reference device 600 installed. FIG. 9D is a perspective drawing showing the exemplary patient reference device 600 installed with sterile draping in place. FIG. 9E is a perspective drawing showing the exemplary patient reference device 600 installed with sterile draping in place. FIGS. 9B-E are now discussed concurrently.

In FIGS. 9B-D, the patient reference device is shown attached to an arm such as the arm 500. The mounting bolt 504 of the arm 500 attaches the arm 500 to a Mayfield clamp 902, or any other suitable head holding device for restraining the head of a patient. Since the patient reference device 600 is therefore rigidly attached to the Mayfield clamp 902, the patient reference device 600 is located in a fixed location relative to the patient's head and therefore relative to the surgical site of interest.

FIGS. 9D-E show the patient reference device 600 with a sterile drape 904 attached, covering arm 500 and other components that are typically not sterilized prior to the medical procedure to be performed. Sterile cover 612 and lens 616 are also shown in position attached to the continuous edge 610 of the patient reference device 600.

In one example, the patient reference device 600 may be sold as a kit for assembly by an end user, such as a hospital or medical clinic. The kit may include the housing 602, the cover 612, the arm 500 having mounting bolt 504 or other suitable connecting mechanism for attaching to a Mayfield clamp, the tightening screw and/or knob 502, the tracking markers 608, and/or the sterile drape 904.

The specific embodiments described above have been shown by way of example, and it should be understood that these embodiments may be susceptible to various modifications and alternative forms. It should be further understood that the claims are not intended to be limited to the particular forms disclosed, but rather to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. 

1. A patient reference device for use during a medical procedure, the patient reference device comprising: a housing having a back side and a front side; at least three tracking markers attached to the front side of the housing; the housing around the at least three tracking markers and beyond a horizontal plane defined by tops of the at least three tracking markers, the housing terminating at a substantially continuous edge; and a sterile cover attached to the substantially continuous edge of the housing for covering the housing and the tracking markers.
 2. The patient reference device according to claim 1, wherein the housing is attachable to a patient reference arm that is attachable to a Mayfield head clamp.
 3. The patient reference device according to claim 1, wherein there are at least four tracking markers attached to the front side of the housing.
 4. The patient reference device according to claim 1, wherein the housing is dome shaped with a flattened back side.
 5. The patient reference device according to claim 1, wherein the tracking markers are selected from the group consisting of passive reflective tracking spheres, active infrared (IR) markers, active light emitting diodes (LEDs), and a graphical pattern.
 6. The patient reference device according to claim 1, further comprising a sensor attached thereto for providing a signal to a medical navigation system.
 7. The patient reference device according to claim 6, wherein the sensor includes at least one of an accelerometer, a strain gauge, and a force sensor.
 8. The patient reference device according to claim 1, wherein the sterile cover includes a lens made of a substantially rigid and substantially transparent plastic.
 9. The patient reference device according to claim 1, wherein the housing is substantially dome shaped with a flattened back side and the sterile cover is substantially round.
 10. The patient reference device according to further comprising: a seal located on the substantially continuous edge for forming a seal between the housing and the sterile cover.
 11. The patient reference device according to claim 8, wherein the lens has the properties of an optical band pass filter.
 12. The patient reference device according to claim 10, wherein the sterile cover further includes a sterile drape attached to the seal for covering the housing and a patient reference arm attached to and holding the patient reference device in position.
 13. (canceled)
 14. A kit comprising parts that can be assembled to form the patient reference device according to claim 1, the kit including instructions for assembling the parts.
 15. A medical navigation system, comprising: a patient reference device for use during a medical procedure, the patient reference device having: a housing having a back side and a front side; at least three tracking markers attached to the front side of the housing; the housing extending around the at least three tracking markers and beyond a horizontal plane defined by tops of the at least three tracking markers, the housing terminating at a substantially continuous edge; and a sensor attached to the patient reference device; a controller at least electrically coupled to the sensor, the sensor providing a signal to the controller indicating movement of the patient reference device.
 16. The medical navigation system according to claim 15, wherein the patient reference device further includes a sterile cover attached to the substantially continuous edge of the housing for covering the housing and the tracking markers.
 17. The medical navigation system according to claim 15, wherein the sensor includes at least one of an accelerometer and a force sensor.
 18. A patient reference device for use during a medical procedure, the patient reference device comprising: a housing having a back side and a front side; at least one tracking marker attached to the front side of the housing; the housing extending around the at least one tracking marker and beyond a top of the at least one tracking marker, the housing terminating at a substantially continuous edge; and a sterile cover attached to the substantially continuous edge of the housing for covering the housing and the tracking marker.
 19. The patient reference device according to claim 18, wherein the at least one tracking marker is selected from the group consisting of passive reflective tracking spheres, active infrared (IR) markers, active light emitting diodes (LEDs), and a graphical pattern.
 20. The patient reference device according to claim 18, wherein the sterile cover includes a lens made of a substantially rigid and substantially transparent plastic.
 21. The patient reference device according to claim 18, wherein the housing is dome shaped with a flattened back and the sterile cover is substantially round.
 22. (canceled)
 23. (canceled)
 24. (canceled)
 25. (canceled)
 26. (canceled) 